Comment on Proposed Regulations and Submit Petitions
Making Your Voice Heard at FDA
Submit Comments Online
You can submit your comments on many of FDA's proposed regulations at Regulations.gov
Proposed Rules | Electronic Submission of Comments | Petitions
As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, tobacco products and medical devices--commodities close to the daily lives of all Americans. FDA rules have considerable impact on the nation's health, industries, and economy. These rules are not created arbitrarily or in a vacuum, rather they are formed with the public's help.
By law, anyone can participate in the rulemaking process by commenting on regulatory actions that FDA proposes. FDA carefully considers all relevant and timely-submitted comments.
Proposed Rules
When FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register on the day the public comment period begins. Published every weekday, the Federal Register is available online. Issues open to public comment often are reported by the news media and can also be found at regulations.gov. Instructions for finding Federal Register documents and submitting comments are found on the Federal Dockets Management System Instruction Sheet.
In the Federal Register, the "notice of proposed rulemaking" describes the planned regulation and provides background on the issue. It also provides instructions for submitting comments and the name of the person to contact for more information.
Also noted is the "comment period," which specifies how long the agency will accept public comments on the proposed rule. The docket usually us open for comments for 60 days, although some comment periods have been as short as ten days or as long as nine months. Weekends and holidays are included in the comment period.
Electronic Submission of Comments
The Federal Dockets Management System Instruction Sheet tells how to submit comments electronically at regulations.gov.
Here are some other suggestions for helping make sure your comment has the greatest possible impact:
- Clearly indicate if you are for or against the proposed rule or some part of it and why. FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.
- Refer to the docket number, listed in Federal Register notice (i.e., FDA-20XX-X-XXXX).
- Include a copy of articles or other references that support your comments. (Electronic attachments will not be forwarded if the "Comment" box is left empty.)
- Only relevant material should be submitted. If an article or reference is in a foreign language, it must be accompanied by an English translation verified to be accurate. Translations should be accompanied by a copy of the original publication.
- To protect privacy when submitting medical information, delete names or other information that would identify patients.
When a comment is received, it is logged in, numbered, and placed in a file for that docket. It then becomes a public record and is available for anyone to examine at regulations.gov or in FDA Dockets Management Staff's public reading room (5630 Fishers Lane, Room 1061, Rockville, MD 20852). Under the Freedom of Information Act (FOIA), visitors to the reading room can receive free copies of comments up to 50 pages if their request is for noncommercial use. After that, each page costs 10 cents. Another option is to send FDA a FOIA request (http://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm) and have copies of comments emailed or mailed to the requestor.
Call FDA's Dockets Management at (240) 402-7500 with questions regarding public reading room, comments, hearing process, and petition submissions.
Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.
Petitions
Another way to influence the way FDA does business is to petition the Agency to issue, change or cancel a regulation, or to take other action. The agency receives approximately 200 citizen petitions annually.
Citizen petitions require careful preparation by the submitter. Individuals or organizations may submit petitions; most are submitted by regulated industry or consumer groups. For example, a consumer group might request safety-related labeling changes for a drug product; or a consumer group might petition FDA to tighten regulation of a certain product.
Types of Petitions submitted to FDA and Requirements:
10.30 - Citizen Petition
- Action Request
- Statement of Grounds
- Environmental Impact
- Economic Impact
- Certification
eCFR :: 21 CFR 10.30 -- Citizen petition.
10.33 - Reconsideration
- Decision Involved
- Action Required
- Statement of Grounds
eCFR :: 21 CFR 10.33 -- Administrative Reconsideration of Action.
10.35 - Administrative Stay of Action
- Decision Involved
- Action Required
- Statement of Grounds
eCFR :: 21 CFR 10.35 -- Administrative Stay of Action.
FDA currently does not accept e-mailed petitions. Petitions can be sent electronically to FDA via Regulations.gov or mailed or delivered to Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
Ultimately, FDA management decides whether to grant a petition. However, agency staff first evaluate the petition, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly.
For more information on submitting petitions, and sample formats, consult Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33, and 10.35.
In addition to accepting public comments and petitions, FDA also schedules public meetings and hearings to discuss and explain its proposals. These usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held with a virtual component, and for in-person meetings, they are often held in the Washington, D.C., metro area, but are sometimes conducted in other areas across the country. Meetings for the public to present views are often announced in the Federal Register.
Contact FDA’s Dockets Management Staff at (240) 402-7500 with questions about the comment, petition, or hearing process Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.